Akebia Therapeutics Q1 2024 Financial Results and Business Highlights

Akebia Therapeutics, Inc. (Nasdaq: AKBA), focused on improving the lives of those affected by kidney disease, announced its financial results for the first quarter of 2024 ending March 31. The company is preparing for the launch of Vafseo® (vadadustat) tablets, which received FDA approval on March 27, 2024, for treating anemia caused by chronic kidney disease (CKD) in adults on dialysis for at least three months. The drug is expected to be available in January 2025.

According to John P. Butler, CEO of Akebia, the FDA's approval of Vafseo is a significant milestone for the company. Launch activities are already in progress to ensure broad access and quick adoption of the drug upon its release. Akebia plans to engage with the FDA by the end of the year to explore potential label expansions for Vafseo and is also working on generating clinical data to uncover additional benefits for patients.

Key business updates include plans to submit an application for Transitional Drug Add-on Payment Adjustment (TDAPA) for Vafseo in June, with acceptance anticipated in July 2024 and TDAPA designation expected by January 2025. Akebia presented research at the 2024 Annual Dialysis Conference on various aspects of vadadustat's safety and efficacy. Additionally, Akebia's licensee Averoa has submitted a marketing authorization application to the European Medicines Agency for Ferric Citrate Coordination Complex.

Financially, Akebia reported $31.0 million in net product revenues for Auryxia® (ferric citrate) for the first quarter of 2024, and it anticipates revenue growth for Auryxia in 2024 compared to 2023. The company has drawn down the second tranche of its $55.0 million BlackRock debt facility, securing net proceeds of $7.5 million. An amendment to its License Agreement with Vifor International Ltd. was also signed to simplify repayment terms through tiered royalties based on Vafseo sales.

Akebia's financial results for the first quarter of 2024 showed total revenues of $32.6 million, compared to $40.0 million in the same period in 2023. Net product revenues were $31.0 million, a slight decrease from $34.7 million in the first quarter of 2023. Research and development expenses also saw a reduction to $9.7 million from $19.7 million in the same period the previous year. The company reported a net loss of $18.0 million, an improvement from a net loss of $26.9 million in the first quarter of 2023. As of March 31, 2024, Akebia's cash and cash equivalents stood at approximately $42.0 million, which is expected to support operations for at least the next two years, including the U.S. launch of Vafseo.

To discuss these results, Akebia scheduled a conference call on May 9 at 8:00 a.m. Eastern Time. The call will be accessible through registration, with an online archive available on the company's website.

Vafseo, a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates the body's response to hypoxia to boost erythropoietin production, thus increasing hemoglobin and red blood cell production for anemia management. It is approved for use in 37 countries.

Despite its benefits, Vafseo has limitations and is not indicated for patients requiring immediate anemia correction or those with CKD not on dialysis. The drug carries several warnings including risks of death, myocardial infarction, stroke, and venous thromboembolism, among others. Patients should be monitored for these adverse reactions, and the drug's use should be adjusted accordingly.

Auryxia, another Akebia product, is contraindicated in patients with iron overload syndromes and carries risks of iron overload and potential overdose in children. The most common adverse reactions for Auryxia include gastrointestinal issues and discolored feces.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!